The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

21951–21975 of 50429

  • HighFDA (Food)·F-0023-2021·2020-10-21

    Lucky Spoon Bakery Recalls Gluten-Free Brownie Bites Due to Gluten Contamination

    Lucky Spoon Bakery is recalling specific lots of Gluten Free Chewy Chocolatey Brownie Bites because a flour supplier's batch tested positive for gluten.

    Product
    Lucky Spoon Bakery Gluten Free Chewy Chocolatey Brownie Bites, 6.6 oz. plastic clam shell containing approximately 12 (6.6 oz.), UPC 8-50489-00315-9, P.O. Box 2954 Salt Lake City, UT 84110. 12 packages/case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0020-2021·2020-10-21

    Lucky Spoon Bakery Recalls Gluten-Free Cupcakes Due to Gluten Contamination

    Lucky Spoon Bakery is recalling gluten-free cupcakes because a flour batch tested positive for gluten. The products were distributed in eight states and nationwide via drop ship.

    Product
    Lucky Spoon Bakery Gluten Free Very Vanilla Cupcakes with Vanilla Buttercream Frosting, 8.0 oz. plastic clam shell containing 4 cupcakes, UPC 8-50489-00309-8, P.O. Box 2954 Salt Lake City, UT 84110. 12 packages/case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0019-2021·2020-10-21

    Lucky Spoon Bakery Recalls Gluten-Free Muffins Due to Gluten Contamination

    Lucky Spoon Bakery is recalling Gluten Free Utterly Almond Muffins because a flour supplier's batch tested positive for gluten.

    Product
    Lucky Spoon Bakery Gluten Free Utterly Almond Muffins, 7.25 oz. plastic clam shell containing 6 muffins, UPC 8-50489-00305-0, P.O. Box 2954, Salt Lake City, UT 84110. 12 packages/case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·20V647000·2020-10-21

    Braun Ambulances Recall 156 Units Due to Display Lockup

    Braun Ambulances is recalling 156 units because the lighting and HVAC display may lock up, potentially delaying emergency operations and increasing crash risk.

    Product
    BRAUN AMBULANCES — BRAUN AMBULANCES EXPRESS PLUS TYPE I, CHIEF XL TYPE III, LIBERTY TYPE I, EXPRESS TYPE III
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0101-2021·2020-10-21

    Siemens ADVIA Fructosamine Test Recalled for Positive Bias

    Siemens is recalling ADVIA Chemistry Systems-Fructosamine tests because results may show a positive bias, potentially leading to incorrect glucose management.

    Product
    ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0095-2021·2020-10-21

    Alcon Custom-Pak Surgical Packs Recalled for Latex Glove Degradation

    Alcon is recalling 16,971 Custom-Pak Surgical Procedure Packs containing Cardinal Health PROTEXIS Latex Micro Surgical Gloves due to a degradation defect that could cause holes or tears.

    Product
    Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0098-2021·2020-10-21

    Fresenius AquaBplus Water Purification Systems Recalled for Electrical Safety Defect

    Fresenius Medical Care is recalling 15 AquaBplus water purification systems due to incorrectly crimped connectors that could cause electrical shock.

    Product
    AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0097-2021·2020-10-21

    Biomet Recalls RingLoc Hip Cups Due to Double Sterilization

    Biomet is recalling 48 RingLoc Bi-Polar Hip System Acetabular Cups because they were gamma sterilized twice, which may compromise functionality and shelf life.

    Product
    (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V645000·2020-10-19

    Mitsubishi Fuso Trucks Recalled for Brake Booster Vacuum Pump Defect

    Mitsubishi Fuso is recalling 2019-2021 FEC7T, FEC9T, and FECZT trucks because heat from the exhaust manifold may crack the brake booster vacuum pump diaphragm, potentially disabling power brake assist.

    Product
    MITSUBISHI FUSO — MITSUBISHI FUSO FEC7T, FEC9T, FECZT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V644000·2020-10-19

    Audi Recalls One 2020 Q3 for Driver's Seat Frame Bolt Defect

    Audi is recalling one 2020 Q3 because the driver's seat frame may be incorrectly bolted to the seat rail, increasing injury risk in a crash.

    Product
    AUDI — AUDI Q3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E079000·2020-10-17

    Fuel Delivery Module Recall Due to Potential Stalling Risk

    Continental Automotive Systems is recalling Vitesco NG2 Fuel Delivery Modules where a plastic burr may block the mixing tube, causing insufficient fuel supply and vehicle stalling.

    Product
    FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E078000·2020-10-16

    Weldon V-Mux Vista IV LCD Displays Recalled for Electrical Lockup

    Akron Brass is recalling Weldon V-Mux Vista IV LCD displays used in emergency vehicles because they may lock up due to voltage spikes, potentially delaying emergency efforts.

    Product
    ELECTRICAL SYSTEM: INSTRUMENT CLUSTER/PANEL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V638000·2020-10-15

    GM Recalls 2014-2016 Chevrolet SS and Caprice PPV for Seat Belt Defect

    General Motors is recalling 1,788 vehicles because a previous repair may have been improper, causing the driver's seat belt tensioner cable to fatigue and separate.

    Product
    CHEVROLET — CHEVROLET CHEVEROLET SS, CAPRICE POLICE PURSUIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21702·2020-10-15

    Peloton Recalls PR70P Bike Pedals Due to Laceration Hazard

    Peloton is recalling PR70P clip-in pedals fitted on bikes sold between July 2013 and May 2016 because they can break unexpectedly, causing laceration injuries.

    Product
    PR70P Clip-In Pedals fitted on Peloton bikes (sold between July 2013 and May 2016)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V637000·2020-10-15

    Genie Recalls 2020 TZ-34 and TZ-50 Trailer-Mounted Boom Lifts

    Genie is recalling 2020 TZ-34 and TZ-50 trailer-mounted boom lifts because under-tightened bolts may affect stability and increase injury risk.

    Product
    GENIE — GENIE TZ-50, TZ-34
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21703·2020-10-15

    Homerygardens Extension Cord Splitters Recalled for Fire Hazard

    Sales BSD is recalling Homerygardens extension cord splitters because the wire size cannot handle the appropriate amp load, posing a fire hazard.

    Product
    Homerygardens™ 4-Outlet, 6-Foot Long Indoor and Outdoor Extension Cord Splitters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2021·2020-10-14

    Medline Recalls Quick Release Gait Belts Due to Buckle Breakage Risk

    Medline Industries is recalling 13,500 Quick Release Gait Belts because the buckle may break due to material degradation from gamma radiation exposure.

    Product
    Quick Release Gait Belt, 60
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0081-2021·2020-10-14

    Biomet Regenerex Primary Taper Cap Recalled for Sterilization Defect

    Biomet is recalling Regenerex Primary Taper Caps because they were not properly aligned for gamma sterilization, potentially leaving them unsterilized.

    Product
    Biomet Regenerex Primary Taper Cap Item Number 141269
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0054-2021·2020-10-14

    Luminex VERIGENE Processor SP Recalled for Heater Failure

    Luminex is recalling one VERIGENE Processor SP system in Missouri due to a hybridization heater failure that may cause incorrect test results.

    Product
    VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·20V633000·2020-10-14

    Toyota Recalls 2020 Highlanders Due to Seat Airbag Deployment Risk

    Toyota is recalling 2020 Highlander and Highlander Hybrid vehicles because incorrect seat trim covers may prevent side airbags from deploying properly, increasing injury risk in a crash.

    Product
    TOYOTA — TOYOTA HIGHLANDER, HIGHLANDER HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2021·2020-10-14

    DJO EMPOWR Tibial Knee Punch Handle Recall Due to Retaining Pin Risk

    Encore Medical is recalling 190 units of DJO EMPOWR Tibial Knee Punch Handles because the retaining pin may fall out, potentially leaving debris in the joint space.

    Product
    DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2021·2020-10-14

    Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability

    Medline Industries is recalling 16 non-sterile Left Heart Kits sold to facilities without sterilization capabilities. The kits were intended to be sterilized prior to use.

    Product
    Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original…
    Category
    Medical Device
    Distribution
    Distributed nationwide